HPV self-sampling in the ED to screen under-screened women
Official title: Developing and Implementing HPV SCREENED (Self-Collection REach and ENgagement in Emergency Departments) to Improve Cancer Equity
Run by Rutgers, The State University of New Jersey · NCT07657104 · Data updated 2026-11-12
This study tests whether giving an HPV self-sampling kit in the emergency department can help under-screened women get screened for cervical cancer and find those with HPV to guide follow-up care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 30 Years to 65 Years |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Rutgers, The State University of New Jersey Academic / other |
| Locations | 2 sites (New Brunswick, New Jersey and 1 other locations) |
| Status | Recruiting |
| Started | October 15, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | September 30, 2027 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT07657104 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Biological women aged 30-65 presenting to the ED who are overdue for cervical screening and meet language, mobility, and residency criteria in New Jersey.
✕Probably not a fit
Women who are pregnant, have a previous hysterectomy or cervical cancer, or are not overdue for screening may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot feasibility trial evaluates implementing HPV self-collection as a primary cervical cancer screening method for women aged 30-65 who are overdue for screening and present to the ED with non-critical illness. Participants receive education and an HPV self-sampling kit to complete in the ED, with immediate return of the specimen. Those who test positive for HPV are navigated to follow-up care at local clinics according to standard guidelines, aiming to reduce barriers to screening for women not regularly using primary care. The study hypothesizes that in-ED distribution and same-day kit return will reduce participant burden compared with mailed self-sampling approaches. The initiative is led by Rutgers with sites at two New Jersey hospitals and targets increasing access to cervical screening in under-screened populations.
Why it matters
Potential benefit: If successful, it could increase early detection of high-risk HPV and improve access to follow-up care for women who rarely use primary care.
How similar studies have gone: Previous mailed HPV self-sampling trials faced participation barriers; this study explores a light-touch, ED-based approach to see if it improves uptake.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * biological women, * no prior hysterectomy or cervical cancer, * not pregnant, * last Pap \>3 years, last co-test \>5 years, or last HPV alone test \>5 years, * speak English or Spanish, * has a working cellphone, * NJ residency * ED patient Exclusion Criteria: * currently pregnant (as diagnostic procedures for cervical cancer are often deferred during pregnancy); * previous hysterectomy; * previous diagnosis of cervical cancer; * current menses
Where it's running
-
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States Recruiting -
University Hospital
Newark, New Jersey, United States Not yet recruiting
Study contacts
- Principal investigator: Sara Heinert, PhD, MPH — Department of Emergency Medicine, Rutgers Robert Wood Johnson Medical School
- Study coordinator: Sara Heinert, PhD, MPH
- Email: sara.heinert@rutgers.edu
- Phone: (732) 235-7872
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.